The Involvement of ATP Sensitive Potassium Channel in Migraine Aura and Migraine Pain.

NCT05565001 | Unknown DMC

• 1 other identifier: H-21028500
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study to investigate whether

• Opening of KATP channels causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways.
• Opening of KATP channels causes migraine aura by induction of CSD.

Conditions

Headache; Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• Dynamic diffusion weighted image (DWI)

  To measure transient diffusivity changes related to levcromakalim-induced CSD during the aura phase of migraine in subjects with migraine with aura.

  Before and after infusion of levcromakalim compared with before and after infusion of saline. Time of measurements is baseline, 20 minutes and 160 minutes after the infusion.

Secondary Outcomes (2)

• Vascular imaging before sumatriptan

  Before and after infusion of levcromakalim compared with before and after infusion of saline. Time of measurements is baseline, 20 minutes and 160 minutes after the infusion.

• Vascular imaging after sumatriptan

  Before and after infusion of sumatriptan. Time of measurements is 200 minutes and 210 minutes after the infusion.

Study Arms (2)

Levcromakalim

ACTIVE COMPARATOR

Intravenous infusion of 1 mg levcromakalim followed by intravenous sumatriptan infusion.

Drug: Levcromakalim

placebo (isotonic saline)

PLACEBO COMPARATOR

Intravenous infusion of placebo (isotonic saline) followed by intravenous sumatriptan infusion.

Drug: Levcromakalim

Interventions

Levcromakalim DRUG

Intravenous administration of levcromakalim or placebo over 20 minutes. After 3 hours from the administration of levcromakalim or placebo, participants will receive intravenous infusion of sumatriptan over 10 minutes.

Levcromakalim; placebo (isotonic saline)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Migraine patients
• years.
• kg.
• Women of childbearing potential must use adequate contraception.

You may not qualify if:

• A history of serious somatic disease
• Any other type of headache (except episodic tension-type headache less than once a month) Daily intake of any medication except contraceptives Contraindications for MRI scan.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish headache center

Copenhagen, Glostrup, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Headache; Migraine with Aura; Migraine without Aura

Interventions

Cromakalim

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Mohammad Al-Mahdi Al-Karagholi

CONTACT

00 45 31 19 16 47; mahdi.alkaragholi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study investigator

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 4, 2022
• Study Start: September 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

DK (1)